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Research

Increased Circulation

Pain Reduction

Studies

11 Studies Published in Peer-Reviewed Journals such as these involving over 4000 subjects.

Increased Circulation

Circulation increases were measured by a Moor Scanning Laser Doppler after a 20 - 30 minute Anodyne treatment. Brighter areas in the images below indicate more circulation.

Before Treatment	After Anodyne Treatment

Heel	Up to 3200% increase


Lower Back	Up to 1300% increase


Elbow	Up to 1300% increase


Knee	Up to 2000% increase

Baseline

	400% Increase			40% Increase
		MIRE	Placebo (Warmth)
Foot – Foot on left treated with Anodyne (MIRE™) showed a 400% increase in circulation while foot on right treated with a placebo heat treatment showed only a 40% increase in circulation.

Click here to learn more about how Anodyne compares to competitive systems.

Pain Reduction

Pain Study #1

Study Site(s):

Joslin Center for Diabetes at Morton Plant Hospital

Number of Subjects:

Study Design:

Prospective, Randomized, Double Blind, Placebo Controlled

Protocol Used:

All subjects in the study had chronic pain and/or circulatory deficiency in the extremities. Subjects initially received treatment with active therapy pads on one limb and sham pads on the other limb 3 times per week for 40 minutes each vist for 2 weeks (6 treatments). This was followed by six active treatments of the same duration administered to both limbs duing the following 2 weeks.

Pain Endpoint:

Numeric Visual Analog Scale from 0 – 10 (10 being the worst pain)

Results :

Group	VAS Baseline	After 6 MIRE Treatments	After12 MIRE Treatments	P Value
1 (N=18)	4.2 + 2.3	3.2 + 1.9	2.3 + 1.7	<0.0001
2* (N=9)	4.2 + 3.9	2.6 + 2.3	2.0 + 2.3	NS
* Patients more impaired

Conclusion:

The results of the study demonstrate that treatments with near-infrared photo energy delivered in the manner specified in the study protocol resulted in a significant reduction in pain.

Pain Study #2

Study Site(s):

Multiple Site

Number of Subjects:

2239

Study Design:

Multiple Site Retrospective Chart Review based on Prospective, Repeated Measures Analysis

Protocol Used:

All subjects in the study had chronic pain and/or circulatory deficiency. The average treatment protocol was 3 x per week for 30-45 minutes for 5 weeks and included physical therapy interventions such as therapeutic exercise, neuromuscular re-education and/or gait training.

Pain Endpoint:

Numeric Visual Analog scale from 0 – 10 (10 being the worst pain)

Results :

Patients Reporting Significant Pain Pre and Post Treatment

Pre	Post	# Improved	% Improved
1563	33	1530	98%

Changes in Pain on 11 point VAS (0-10; 10 being the worst pain)

Pre	Post	# Points Improved	P-Value	% Improved
7.2 ± 2.2	2.4 ± 2.1	4.8 ± 2.4	<0.0001	67%

Conclusion:

MIRE treatments are associated with a reduction in pain, even in patients with pain levels between 8-10 on a 0-10 point scale.

Pain Study #3

Study Site(s):

Genesis Medical Center (Davenport, IA), Premier PT (Evergreen Park, IL, Orland Park, IL and Hinsdale, IL), Westside Retirement Village (Indianapolis, IN), Sonoma Valley Hospital (Sonoma, CA), Helmwood Healthcare (Elizabethtown, KY)

Number of Subjects:

272

Study Design:

This was a retrospective Chart Review in 7 facilities and was based on Prospective, Repeated Measures Analysis.

Protocol Used:

All subjects in the study had chronic pain and/or circulatory deficiency. The therapy intervention included Anodyne Therapy for pain and circulation and physical therapy interventions such as therapeutic exercise, neuromuscular re-education and/or gait training 3 x per week for an average of 6 weeks.

Pain Endpoint:

Numeric Visual Analog scale from 0 – 10 (10 being the worst pain)

Results :

Patient Demographics (Pre-Treatment)

	Total
Patients	272
Male	135
Female	137
Ageª	69 ± 12.3
Mean Number of Treatments	18 ± 10.2
Treatment Time (in minutes)	34.2 ± 9.4

Pain Pre and Post Treatment

All Patients (Pain > 4)	(n = 257)
VAS Pre-Treatment	7.7 ± 1.2
VAS Post-Treatment	4.8a ± 2.2
VAS Decreases	2.9 ± 2.2
% Pain Reduction	38%
Horrible to Excruciating Pain (VAS 8.5-10)	(n = 37)
VAS Pre-Treatment	9.4 ± 0.5
VAS Post-Treatment	4.8a ± 2.7
VAS Decreases	4.6 ± 2.9
% Pain Reduction	49%
Distressing Pain (VAS 6.5-8)	(n = 189)
VAS Pre-Treatment	7.8 ± 0.4
VAS Post-Treatment	5.0a ± 1.9
VAS Decreases	2.8 ± 1.9
% Pain Reduction	36%
Discomforting Pain (VAS 4-6)	(n = 31)
VAS Pre-Treatment	5.3 ± 0.9
VAS Post-Treatment	3.5a ± 2.5
VAS Decreases	1.8 ± 2.4
% Pain Reduction	34%
a = Values expressed as mean ± SD; All post treatment measures are P<0.0001 vs. Pretreatment

Conclusion:

Use of MIRE in combination with other physical therapy interventions is associated with reduced pain.

Pain Study #4

Study Site(s):

Multiple Sites

Number of Subjects:

252

Study Design:

Retrospective Chart Review and Patient Questionnaire

Protocol Used:

All subjects in the study had chronic pain and/or circulatory deficiency in the extremities. The initial therapy intervention included Anodyne Therapy for pain and circulation and physical therapy interventions such as therapeutic exercise, neuromuscular re-education and/or gait training. Patients then used an Anodyne Therapy System at home for an average of 8 months after the initial treatment in a clinical setting.

Pain Endpoint:

Numeric Visual Analog scale from 0 – 10 (10 being the worst pain)

Results :

Pain Reduction Based on Average Number of Months Using MIRE

	1-3	3-6	6-9	9-12	12+
# of Patients	36	33	22	94	67
Ave. Months after MIRE Clinical Treatment	1.2	4.0	6.7	10.1	13.3
Mean Age	75	74	76	76	76
Male/Female	23/14	20/13	9/13	44/50	40/27
% of Patients Reporting Reduction in Pain	94%	80%	91%	85%	91%

Conclusion:

The medical records indicated that 220 out of 252 patients (87%, p< 0.0001) obtained substantial reduction in pain. When patients have continuing access to MIRE in their homes following clinical treatment, there is a significant reduction in pain.

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